Fucidin Tablets
Leo Laboratories Limited 
1. Name of the medicinal product
Fucidin® Tablets
2. Qualitative and quantitative composition
Each tablet contains Sodium Fusidate Ph.Eur. 250 mg.
3. Pharmaceutical form
Tablet
4. Clinical particulars
4.1 Therapeutic indications
Fucidin® is indicated in the treatment of all staphylococcal infections due to susceptible organisms such as: cutaneous infections, osteomyelitis, pneumonia, septicaemia, wound infections, endocarditis, superinfected cystic fibrosis.

Fucidin® should be administered intravenously whenever oral therapy is inappropriate, which includes cases where absorption from the gastro-intestinal tract is unpredictable.
4.2 Posology and method of administration
For staphylococcal cutaneous infections:

Adults:
 Standard Dose: 250mg (one tablet) sodium fusidate (equivalent to 240mg fusidic acid) twice daily for 5-10 days.

For staphylococcal infections such as osteomyelitis, pneumonia, septicaemia, wound infections, endocarditis, superinfected cystic fibrosis.
Adults:
 Standard dose: 500mg (two tablets) sodium fusidate (equivalent to 480mg fusidic acid) three times daily.

In severe cases of fulminating infections, the dosage may be doubled or appropriate combined therapy may be used.

Elderly: No dosage alterations are necessary in the elderly.

Since Fucidin® is excreted in the bile, no dosage modifications are needed in renal impairment.

The dosage in patients undergoing haemodialysis needs no adjustment as Fucidin® is not significantly dialysed.
4.3 Contraindications
Hypersensitivity to fusidic acid and its salts, or to any of the excipients.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.4 Special warnings and precautions for use
Fucidin® must not be co-administered with statins. There have been reports of rhabdomyolysis (including some fatalities) in patients receiving this combination (see section 4.5). In patients where the use of systemic Fucidin® is considered essential, statin treatment should be discontinued throughout the duration of Fucidin® treatment. The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness. Statin therapy may be re-introduced seven days after the last dose of Fucidin®. In exceptional circumstances, where prolonged systemic Fucidin® is needed e.g for the treatment of severe infections, the need for co-administration of statin and Fucidin® should only be considered on a case by case basis and under close medical supervision.

Fusidic acid is metabolised in the liver and excreted in the bile. Caution should be exercised with other antibiotics which have similar biliary excretion pathways e.g. lincomycin and rifampicin. Elevated liver enzymes and jaundice have occurred during systemic therapy but are usually reversible on discontinuation of the drug (see section 4.8).

Periodic liver function tests should be carried out when the product is given:

• in high oral doses

• for prolonged periods

• to patients with liver dysfunction

• to patients taking potentially hepatotoxic medication

• to patients with biliary t